Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
Week in Review Highlight of the Week:
This week, HHS released final guidance for the second cycle of Medicare drug price negotiations and CMS released the 2026 Notice of Benefit and Payment Parameters proposed rule.
I. Regulations, Notices & Guidance
- On September 30, 2024, the Department of Health and Human Services (HHS) released a notice entitled, Announcement of Solicitation of Written Comments on Proposed Healthy People 2030 Objectives. HHS solicits written comments from the public on 12 new objectives proposed to be added to Healthy People 2030, and written comments from the public proposing additional new core, developmental, or research objectives or topics to be included in Healthy People 2030. Public comment informed the development of Healthy People 2030. HHS will provide opportunities for public input periodically throughout the decade to ensure Healthy People 2030 reflects current public health priorities and public input. The updated set of Healthy People 2030 objectives and topics will reflect further review and deliberation by federal Healthy People topic area workgroups, the Federal Interagency Workgroup on Healthy People 2030, and other federal subject matter experts.
- On September 30, 2024, the Centers for Medicare & Medicaid Services (CMS) released an interim final action entitled, Medicare Program; Changes to the Fiscal Year 2025 Hospital Inpatient Prospective Payment System (IPPS) Rates Due to Court Decision. This interim final action with comment period (IFC) implements revised Medicare wage index values for fiscal year (FY) 2025, establishes a transitional payment exception for low wage hospitals significantly impacted by those revisions, and makes conforming changes to the hospital Inpatient Prospective Payment System (IPPS) payment rates for FY 2025. These changes reflect the removal of the low wage index hospital policy following the appellate court decision in Bridgeport Hosp. v. Becerra. This interim final action also makes conforming changes to IPPS rates and factors used to determine certain payments under the Long-Term Care Hospital Prospective Payment System (LTCH PPS).
- On October 1, 2024, the Food and Drug Administration (FDA) released a notice entitled, Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence; Program Announcement. FDA is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE). Quantitative medicine (QM) is used to inform premarket product review, post-market product assessment, policy development, and policy implementation within several CDER offices. The QM CoE will act as a coordinating body that drives innovation and facilitates integration of QM methodologies and principles across CDER. To realize this purpose, the QM CoE will introduce new activities and coordinate existing activities in key areas, including multidisciplinary education and exchange, development and implementation of applied science policy, knowledge management, and community engagement.
- On October 2, 2024, the Centers for Disease Control and Prevention (CDC) released a notice entitled, Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee. CDC is seeking nominations for membership on the World Trade Center (WTC) Health Program Scientific/Technical Advisory Committee (STAC), in accordance with provisions of the James Zadroga 9/11 Health and Compensation Act of 2010, as amended. The STAC consists of 17 members including experts in fields associated with occupational medicine, pulmonary medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, and mental health, and representatives of WTC responders as well as representatives of certified-eligible WTC survivors.
- On October 2, 2024, HHS released a proposed rule entitled, HHS Acquisition Regulation: Regulatory Review. HHS is proposing to amend and update its Health and Human Services Acquisition Regulation (HHSAR) to update and streamline the HHSAR. Under this initiative, all parts of the regulation were reviewed to streamline the regulation, to revise or remove policy superseded by changes in the Federal Acquisition Regulation (FAR), to remove any procedural guidance that is internal to HHS into a new HHS Acquisition Manual (HHSAM) as internal policies, guidance, and instructions. The rule would add new coverage to implement agency unique requirements. The HHSAR would also be updated to reflect organizational changes within HHS, incorporate recent statutory changes and government mandates, and to accomplish editorial revisions for clarification.
- On October 2, 2024, HHS released a notice entitled, Charter Renewal of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. As stipulated by the Federal Advisory Committee Act, HHS is hereby giving notice that the charter for the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria (PACCARB) has been renewed.
- On October 2, 2024, HHS released a notice entitled, Charter Renewal of the Secretary’s Advisory Committee on Human Research Protection. HHS is hereby giving notice that the charter for the Secretary’s Advisory Committee on Human Research Protection (SACHRP) has been renewed.
- On October 4, 2024, HHS released a request for information (RFI) entitled, To Inform the Development of the 2026–2030 National HIV/AIDS Strategy and the National Strategic Plans for Sexually Transmitted Infections, Vaccines, and Viral Hepatitis. Through this RFI, the Office of Infectious Disease and HIV/AIDS Policy (OIDP) in the Office of the Assistant Secretary for Health (OASH) in the Office of the Secretary, HHS, invites feedback from Federal, State, Tribal, territorial, and local governments; community-based organizations and faith-based organizations; Urban Indian Organizations; health plans and payers; health care providers, and other health-related and social services organizations; private-sector entities; researchers and academic institutions; people living with and who experience risk for disease; and other interested constituents on Strategic Plans to serve as national roadmaps to guide efforts to address HIV, sexually transmitted infections (STI), and viral hepatitis, and to improve and enhance the development and use of vaccines in the U.S.
- On October 4, 2024, CMS released a proposed rule entitled, Notice of Benefit and Payment Parameters for 2026 and Basic Health Program. This proposed rule includes payment parameters and provisions related to the HHS-operated risk adjustment and risk adjustment data validation (HHS-RADV) programs, as well as 2026 benefit year user fee rates for issuers that participate in the HHS-operated risk adjustment program and the 2026 benefit year user fee rates for issuers offering qualified health plans (QHPs) through Federally-facilitated Exchanges (FFEs) and State-based Exchanges on the Federal platform (SBE-FPs). This proposed rule also includes proposed requirements related to modifications to the calculation of the Basic Health Program (BHP) payment; and changes to the Initial Validation Audit (IVA) sampling approach and Second Validation Audit (SVA) pairwise means test for HHS-RADV. It also addresses HHS’ authority to engage in compliance reviews of and take enforcement action against lead agents of insurance agencies for violations of HHS’ Exchange standards and requirements; HHS’ system suspension authority to address noncompliance by agents and brokers; an optional fixed-dollar premium payment threshold; proposed reconsideration standards for certification denials; proposed changes to the approach for conducting Essential Community Provider (ECP) certification reviews; a proposal to publicly share aggregated, summary-level Quality Improvement Strategy (QIS) information on an annual basis; and proposed revisions to the medical loss ratio (MLR) reporting and rebate requirements for qualifying issuers that meet certain standards.
Event Notices
October 7, 2024: FDA announced a meeting of the FDA Science Board. This is a virtual meeting open to the public.
October 8, 2024: The National Institutes of Health (NIH) announced a meeting of the NIH Office of the Director. This is a virtual meeting open to the public.
October 10, 2024: FDA announced a meeting of the Cardiovascular and Renal Drugs Advisory Committee. This is a hybrid meeting open to the public.
October 16-17: The Health Resources and Services Administration (HRSA) announced a meeting of the Advisory Committee on Infant and Maternal Mortality (ACIMM). This is a hybrid meeting open to the public.
October 16-17, 2024: CDC announced a meeting of the Community Preventive Services Task Force. This is a virtual meeting open to the public.
October 21, 2024: HHS announced a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. This is a hybrid meeting open to the public.
October 21-22, 2024: HHS announced a meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis, and Sexually Transmitted Disease (STD) Prevention and Treatment. This is a hybrid meeting open to the public.
October 22, 2024: CDC announced a meeting of the Advisory Committee to the Director (ACD). This is a hybrid meeting open to the public.
October 22-23, 2024: HRSA announced a meeting of the National Advisory Council on Migrant Health. This is a hybrid meeting open to the public.
October 30, 2024: FDA announced a meeting of the Patient Engagement Advisory Committee. This is a virtual meeting open to the public.
October 31, 2024: FDA announced a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. This is a hybrid meeting open to the public.
November 6, 2024: CDC announced a meeting of the Clinical Laboratory Improvement Advisory Committee. This is a virtual meeting open to the public.
November 7, 2024: CDC announced a meeting of the Mine Safety and Health Research Advisory Committee. This is a hybrid meeting open to the public.
November 12, 2024: NIH announced a meeting of the Diabetes Mellitus Interagency Coordinating Committee. This is a hybrid meeting open to the public.
November 14, 2024: HRSA announced a meeting of the Advisory Committee on Heritable Disorders in Newborns and Children. This is a virtual meeting open to the public.
November 15, 2024: HRSA announced a meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. This is a virtual meeting open to the public.
November 21, 2024: FDA announced a meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee. This meeting is open to the public.
II. Reports, Studies, & Analyses
- On October 2, 2024, the U.S. Government Accountability Office (GAO) released a report entitled, Health Care Transparency: CMS Needs More Information on Hospital Pricing Data Completeness and Accuracy. In this report, GAO detailed the limitations in CMSs enforcement of hospital pricing data accuracy and completeness. Although CMS began requiring hospitals to post prices in 2021, stakeholders faced difficulties comparing prices due to inconsistent file formats and incomplete data. In response, CMS updated its requirements in 2024, mandating standardized data formats and penalizing non-compliant hospitals by issuing over $4 million in fines. However, CMS lacks a thorough process to ensure that the data posted are accurate and complete, prompting GAO to recommend stronger enforcement measures, including random sampling and risk-based checks, to ensure the data’s usability for increasing competition and reducing healthcare costs. CMS’s enforcement actions reveal efforts to improve compliance, but concerns remain about whether the pricing data is sufficiently accurate for health plans, researchers, and patients to make informed decisions. In the report, GAO urges CMS to assess pricing data completeness and consider more cost-effective enforcement strategies, ensuring the data effectively promotes competition in healthcare pricing given the rise in private health plan spending from 2012 to 2022.
- On September 30, 2024, CMS released a report following a study on the Acute Hospital Care at Home Initiative (AHCAH) initiative entitled, Report on the Study of the Acute Hospital Care at Home Initiative (AHCAH). The report provides an in-depth analysis of the program, which allows Medicare-certified hospitals to offer inpatient-level care at home. Originally launched during the COVID-19 public health emergency (PHE), AHCAH was extended through December 2024 under the Consolidated Appropriations Act, 2023 (CAA, 2023). The report evaluates various aspects of the initiative, including patient selection, demographics, clinical conditions treated, and a comparison of care quality and costs between AHCAH and traditional inpatient settings. The report found that AHCAH patients tend to be urban, white, and less likely to receive Medicaid. Additional AHCAH recipients often receive treatment for chronic conditions including respiratory and circulatory issues. Additionally, the report compared AHCAH care quality to brick-and-mortar hospital care, showing lower mortality rates and mixed results on readmissions. Moreover, AHCAH utilization was generally lower for AHCAH patients post-discharge. Finally, the report highlights that while AHCAH showed promising results in cost reduction and quality of care, more research is necessary to confirm its long-term benefits. Positive patient and caregiver experiences support the program’s expansion, but its future after 2024 depends on congressional action. The report calls for further refinement in data collection and evaluation of AHCAH’s impact on the health care system, emphasizing the need for better targeted metrics in future studies. A face sheet on the report is available here.
- On October 4, 2024, the Congressional Budget Office (CBO) released a report entitled, Alternative Approaches to Reducing Prescription Drug Prices. In this report, CBO discusses the factors underlying prescription drug prices and examines a set of policy approaches aimed at reducing those prices. The agency assesses how each approach, if implemented in 2025, would affect average drug prices for purchasers in the United States in 2031. Some of the approaches that CBO examined aim to reduce prescription drug prices by capping them or limiting their growth; others would reduce prices by promoting price competition or affecting the flow of information.
III. Other Health Policy News
- On October 2, 2024, HHS and CMS released final guidance outlining the process for the second cycle of negotiations under the Medicare Drug Price Negotiation Program. The Inflation Reduction Act of 2022 (IRA) established this program to allow Medicare to negotiate directly with drug companies for the prices of certain high expenditure single-source brand-name Medicare Part B and Part D drugs without generic or biosimilar competition. On August 29, 2023, CMS announced the 10 Medicare Part D drugs selected for the first cycle of price negotiations, and the negotiated prices for these drugs will become effective on January 1, 2026. These negotiated prices are estimated to save people enrolled in Medicare prescription drug coverage around $1.5 billion in out-of-pocket costs in 2026.
- According to the final guidance, CMS will announce the selection of up to 15 additional drugs covered by Medicare Part D for the second cycle of negotiations by February 1, 2025. This second cycle of negotiations with participating drug companies will occur during 2025, and any negotiated prices for this second set of drugs will be effective starting January 1, 2027. The guidance also explains how CMS intends to ensure that people with Medicare can access drugs at the negotiated prices and outlines changes to patient-focused engagement events, which are intended to help CMS better understand patient experiences with the selected drugs and their therapeutic alternatives. The press release is available here. The final guidance is available here.
- On October 2, 2024, CMS announced the availability of accelerated and advance payments for Medicare fee-for-service (FFS) providers and suppliers affected by Hurricane Helene. These payments are intended to alleviate cash flow issues caused by disrupted operations in Federal Emergency Management Agency (FEMA)-designated disaster areas. Eligible Medicare Part A providers and Part B suppliers can request payments equivalent to up to 90 days of prior claims, which will later be recouped through future Medicare claims over a 90-day period. CMS is also offering flexibility in repayment schedules for providers with existing debts, allowing for temporary adjustments without financial documentation. Additionally, CMS will provide relief for disruptions in debt communications due to postal service delays, offering the option for overpayment demand letters to be reissued once mail services resume.
- To qualify for accelerated or advance payments, providers must be enrolled in Medicare with a clean billing history, free from fraud investigations, and must have billed Medicare within 90 days prior to the disaster. Providers already on repayment schedules may request modifications, including interest-only payments, for a limited period. Providers can seek assistance by contacting their respective Medicare Administrative Contractors (MACs). A press release with more information is available here.
- On September 30, 2024, the Biden Administration announced $68.5 million in grants through the Substance Abuse and Mental Health Services Administration (SAMHSA) to support behavioral health education, training, and community programs. This funding aligns with President Biden’s Unity Agenda to improve access to mental health and substance use services nationwide. Grants target a range of initiatives, including recruiting minority behavioral health professionals, training rural Emergency Medical Services (EMS)workers, supporting outpatient treatment for individuals with serious mental illness, enhancing suicide prevention on college campuses, and integrating behavioral health with primary care. Key funding includes $9 million for the Addiction Technology Transfer Centers Cooperative Agreements to strengthen the workforce in providing substance use disorder (SUD) treatment and recovery support services. Additionally, $2.7 million is allocated for the National Center of Excellence for Integrated Health Solutions, which advances primary and behavioral health care integration through training and technical assistance to healthcare providers. Other notable grants include $15.4 million for the Minority Fellowship Program to recruit and train professionals in behavioral health, particularly for minority populations, and $11.5 million for rural EMS training to equip first responders in rural areas with trauma-informed care skills. Programs aimed at HIV care, mental health in colleges, and treating unsheltered populations also receive specific funding, all contributing to a comprehensive approach to addressing behavioral health challenges. A press release with more information is available here.
- On September 30, 2024, HHS finalized the 2024-2030 Federal Health IT Strategic Plan to drive systemic improvements in health care using health IT. Developed collaboratively with over 25 federal agencies, the plan outlines strategies to enhance health care delivery, promote wellness, foster innovation, and connect health systems with data. A press release with more information is available here. The 2024-2030 Federal Health IT Strategic Plan is available here.
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